Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years. FDA does not endorse either the product or the company.AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug producAurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product.
FDA and international regulators have identified N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and NMBA in ARBs.These methods should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.Agency scientists evaluated the risk of exposure to NMBA at levels up to 9.82 ppm and determined that it presents no meaningful difference in cancer risk over a six-month time period when compared to a lifetime of exposure to NMBA at 0.96 ppm. FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities. Instructions for returning recalled products are given in the recall letter.Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.The meta-analysis included data from over 60,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Recalls, Market Withdrawals, & Safety Alerts * The acceptable intake is a daily exposure to a compound such as NDMA, NDEA, or NMBA that approximates a 1:100,000 cancer risk after 70 years exposureMacleods is only recalling lots of losartan-containing medication where NDEA has been detected above the Torrent is only recalling lots of losartan-containing medication containing NDEA above the Solco is only recalling lots of irbesartan-containing medication where NDEA has been detected above the The agency also updated the list of irbesartan products under recall.Torrent is only recalling lots of losartan medication containing NDEA above the interim Aurobindo is recalling lots of valsartan-containing medication that tested positive for NDEA above the interim The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-Nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above interim acceptable daily intake levels.FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. If a manufacturer detects a new impurity or higher level of impurities, they should fully evaluate the impurities and take action to ensure the product is safe for patients.
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